Generic Name and Formulations:
Obinutuzumab 25mg/mL; soln for IV infusion after dilution; preservative-free.
Company:
Genentech, Inc.
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02/28/14 |
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Monograph added. |
Indications for GAZYVA:
Treatment of patients with previously untreated chronic lymphocytic leukemia (CLL), in combination with chlorambucil.
Adult Dose for GAZYVA:
Premedicate (eg, glucocorticoid, APAP, antihistamine) before each infusion. Give by IV infusion for 6 treatment cycles (28 days duration). Cycle 1: 100mg on Day 1 at 25mg/hr over 4 hours; 900mg on Day 2 at 50mg/hr, may increase at 50mg/hr every 30mins (max 400mg/hr); 1000mg on Days 8 and 15 at 100mg/hr, may increase by 100mg/hr increments every 30mins (max 400mg/hr); Cycles 2–6: 1000mg on Day 1 at 100mg/hr, may increase by 100mg/hr increments every 30mins (max 400mg/hr). Infusion rate and premedication adjustments: see full labeling.
Children's Dose for GAZYVA:
Not established.
Pharmacological Class:
Cytolytic monoclonal antibody (CD20-directed).
Warnings/Precautions:
Risk of hepatitis B virus (HBV) reactivation; immediately discontinue and any concomitant chemotherapy if occurs. Screen for HBV infection prior to initiation; if positive evidence, monitor and consider antiviral therapy. Discontinue treatment and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressives if PML develops. Monitor closely for infusion reactions; if Grade 4: discontinue permanently; if Grade 3: interrupt until resolved; if Grade 1 or 2: interrupt or reduce the infusion rate and manage symptoms. Preexisting cardiac or pulmonary conditions: monitor more frequently during and post-infusion period for severe reactions. Risk of TLS in high tumor burden and/or high circulating lymphocyte count (>25 x 109/L): prophylaxis with antihyperuricemics and hydration. Active infection: do not administer. Monitor for bleeding; obtain blood and platelet counts frequently. Risk of neutropenia; give antimicrobial prophylaxis. Pregnancy (Cat. C). Nursing mothers: not recommended.
Interactions:
Concomitant live viral vaccines: not recommended. Consider withholding antihypertensives for 12hrs prior to, during, and for 1hr after infusion until BP is stable.
Adverse Reactions:
Infusion reactions, neutropenia, thrombocytopenia, anemia, pyrexia, cough, musculoskeletal disorders.
How Supplied:
Single-use vial (40mL)—1
